Status:
COMPLETED
Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-14
Lead Sponsor:
Meridian Bioscience, Inc.
Collaborating Sponsors:
Conatus Pharmaceuticals Inc.
Conditions:
NASH - Nonalcoholic Steatohepatitis
Cirrhosis
Eligibility:
All Genders
18+ years
Brief Summary
To validate the ability of the Methacetin Breath Test (MBT) to detect clinically significant portal hypertension (CSPH)/severe portal hypertension (SPH) defined as hepatic venous pressure gradient (HV...
Detailed Description
This study is a companion protocol that will use the data generated by Conatus' study of emricasan under protocol IDN-6556-14 (NCT02960204).The IDN-6556-14 study is a Phase 2, multicenter, double-blin...
Eligibility Criteria
Inclusion
- Male or female subjects 18 years or older, able to provide written informed consent and able to understand and willing to comply with the requirements of the study.
- Cirrhosis due to NASH with exclusion of other causes of cirrhosis (e.g. chronic viral hepatitis, alcoholic liver disease, etc.)
- Compensated cirrhosis OR Decompensated cirrhosis with no more than 1 prior significant decompensating event.
- Severe portal hypertension defined as HVPG ≥12 mmHg
- Subjects who are on NSBB, nitrates, diuretics, lactulose, rifaximin, or statins must be on a stable dose for at least 3 months prior to Day 1
- Willingness to utilize effective contraception (for both males and females of childbearing potential) from Screening to 4 weeks after the last dose of study drug
Exclusion
- Evidence of severe decompensation
- Severe hepatic impairment defined as a Child-Pugh score ≥10
- ALT \>3 times upper limit of normal (ULN) or AST \>5 times ULN during screening
- Estimated creatinine clearance \<30 mL/min
- Prior transjugular intrahepatic portosystemic shunt or other porto-systemic bypass procedure
- Known portal vein thrombosis
- Symptoms of biliary colic, e.g. due to symptomatic gallstones, within the last 6 months, unless resolved following cholecystectomy, other definitive treatment (e.g. sphincterotomy), or medical management (e.g. ursodeoxycholic acid)
- Current use of medications that are considered inhibitors of OATP1B1 and OATP1B3 transporters
- Alpha-fetoprotein \>50 ng/mL
- History or presence of clinically concerning cardiac arrhythmias, or prolongation of screening (pre-treatment) QTcF interval of \>500 msec
- History of or active malignancies, other than those successfully treated with curative intent and believed to be cured
- Prior liver transplant
- Change in diabetes medications or vitamin E within 3 months of screening
- Uncontrolled diabetes mellitus (HbA1c \>9%) within 3 months of screening
- Significant systemic or major illness other than liver disease
- HIV infection
- Use of controlled substances (including inhaled or injected drugs) or non-prescribed use of prescription drugs within 1 year of screening
- If female: planned or known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding
- Previous treatment with emricasan or active investigational medication (except methacetin) in a clinical trial within 3 months prior to Day 1
Key Trial Info
Start Date :
August 28 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2019
Estimated Enrollment :
343 Patients enrolled
Trial Details
Trial ID
NCT03439189
Start Date
August 28 2016
End Date
May 13 2019
Last Update
December 20 2022
Active Locations (1)
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1
Hopital Beaujon
Clichy, France, 92118